- Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial (fiercepharma.com)
Generic giant Mylan has faced a slew of lawsuits targeting its EpiPen marketing strategies. Now known as Viatris, the drugmaker says it's scored a win against serious charges in an antitrust case that's been running for several years...The case dates back to 2017 when the plaintiffs...charged Mylan with a number of anticompetitive strategies to build and maintain its EpiPen empire...Mylan also paid excessive rebates to pharmacy benefit managers, commercial payers and state Medicaid programs as long as they didn't reimburse competing products, plaintiffs said. They further cited the well-known and dramatic price hikes Mylan implemented over the years...READ MORE
- CVS cut 72 drugs with ‘hyperinflated’ prices from its formulary last year (fiercehealthcare.com)
Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14...This is an example of a growing trend: medications, including many generics, with "hyperinflated" prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018...CVS first launched a program to address hyperinflated drugs in 2017, and it pulls drugs from its formulary when they have a far cheaper equivalent or if the price doesn't match up with quality metrics...READ MORE
- HHS Withdraws Advisory Opinion on 340B Drug Discount Program (biospace.com)Drugmakers dig in and signal fight over HRSA's demands to reverse 340B contract pharmacy policies (fiercehealthcare.com)Transparency in Drug Pricing Can Start With 340B (drugtopics.com)
On December 30, 2020, the Department of Health and Human Services issued an advisory opinion on the 340B Program...This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers. The opinion was designed to address whether drugmakers could refuse to sell drugs to those pharmacies at the “ceiling price.”...AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi turned around and sued HHS over the issue...HHS responded saying it “never intended to do what plaintiffs in those suits allege: to create new, binding obligations on plaintiffs or to serve as the predicate for enforcement against those plaintiffs.”...READ MORE
- ‘We’re Not Gonna Take It’—Bayer and Twisted Sister rocker join nonprofit to push back on prostate cancer (fiercepharma.com)
Heavy metal band Twisted Sister urged '80s teens to stand up and say, “We’re not gonna take it.” Now, founding band member Jay Jay French is teaming up with Bayer to convince the now grown-up teens to take the same stance against prostate cancer…French, a guitarist who also managed Twisted Sister, knows from personal experience why it’s important. His father died from prostate cancer, and French himself was diagnosed in 2018… French and Bayer, along with prostate cancer patient organization Zero – the End of Prostate Cancer, are working together on the social media and digital We’re Not Gonna Take It campaign…READ MORE
- U.S. lawmakers to investigate approval, pricing of Alzheimer’s drug from Biogen (reuters.com)
U.S. lawmakers...announced an investigation into the approval and pricing of Biogen Inc's Alzheimer's drug, Aduhelm, amid concerns over its steep price and doubts if the clinical evidence proves the drug works...The drug, which has a list price of $56,000 per year, was approved by the U.S. regulators as the first treatment to attack a likely cause of Alzheimer's..."We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit," House Committee on Oversight and Reform said in a statement...READ MORE
- Data Supports Use of Anti-Parasitic Drug Ivermectin in COVID-19 Patients, Study Shows (biospace.com)
Use of the anti-parasitic drug ivermectin could reduce COVID-19-related deaths, data from a peer-reviewed study shows...The study, published last week in the American Journal of Therapeutics, analyzed data from multiple clinical studies assessing ivermectin as a potential treatment for COVID-19. Ivermectin, which is approved by the U.S. Food and Drug Administration as a treatment for intestinal strongyloidiasis and onchocerciasis...The latest assessment of those multiple studies seems to confirm the potential of ivermectin against COVID-19. However, the FDA currently maintains a web page warning against the unauthorized use of ivermectin to treat the virus...The FDA notes that clinical studies are underway assessing ivermectin against COVID-19, but until those are reviewed and confirmed, it will warn against taking unauthorized medication...READ MORE
- Johnson & Johnson among companies excluding Colorado residents from remote job openings after new state law (fiercepharma.com)90 Companies are avoiding hiring in Colorado (coloradoexcluded.com)
A senior manager in operations at Johnson & Johnson. A sales specialist at McKesson. A manager for international tax planning at Cardinal Health...What do these recent postings for remote jobs have in common?...All specify that those who live in Colorado need not apply...The issue, it seems, is Colorado’s Equal Pay for Equal Work Act, which requires companies to disclose the pay range for job openings. The goal of the new law, which went into effect on Jan. 1, is to narrow gender wage disparities by in part forcing salary transparency. Instead, companies that prefer not to disclose pay are barring remote workers from the state...READ MORE
- FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots (reuters.com)Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk, FDA says (fiercepharma.com)
The U.S. drug regulator...added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use...For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said...READ MORE
- S.Africa’s Ramaphosa accuses Big Pharma of ‘selfish, unjust’ vaccine policy (reuters.com)
South Africa's president said...the "selfish, unjust" refusal of pharmaceutical companies and allied Western governments to entertain emergency patent waivers on COVID-19 vaccines was endangering the entire world...In unusually impassioned remarks, Cyril Ramaphosa lambasted a resistance to calls by India and South Africa for temporary patent waivers to ramp up production...The proposed waiver from the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights has support in principle from U.S. President Joe Biden and French President Emmanuel Macron...But the pharmaceutical industry is against the waiver, as are Germany, Switzerland and the World Bank. They argue it would stifle innovation and that vaccine supplies are constrained by a lack of manufacturing capacity...READ MORE
- Key senator calls for Woodcock’s removal as FDA fallout from Biogen Alzheimer’s approval heats up (fiercepharma.com)
The FDA’s fallout from its controversial approval of Biogen’s Alzheimer’s drug Aduhelm is rolling on with one pivotal Democratic lawmaker calling on the administration to dethrone the agency’s top decision-maker...Sen. Joe Manchin called on President Joe Biden in a letter...to oust the FDA’s interim commissioner Dr. Janet Woodcock...The moderate Democrat took aim at the FDA’s decision last week to approve Biogen’s Aduhelm, also known as aducanumab, for Alzheimer’s patients despite intense controversy over whether the treatment actually helps with cognitive decline...READ MORE